Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, UAT planning and execution, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, -
B.S. in a scientific or allied health field and 4-6 years of work experience in Biotech, Pharmaceutical or CRO Industry.
- Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
- Reviews clinical study protocols and provides input
- Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
- Prepares and delivers presentations at internal and external meetings
- Evaluates and mitigates risks to timelines and quality
- Provides input regarding project resource requirements
- Responsible for all aspects of the CDM study deliverables
- Understands cross-functional team roles within Clinical Development
- Has a good understanding of Good Clinical Data Management practices, cross-functional roles and responsibilities
- Demonstrates working knowledge and efficient use of EDC systems and processes, familiarity with industry standards
- Displays sound project management skills and ability to prioritize workload
- EDC experience - including: Time and Events design, Form development, Rule development, vendor management (related to database build)
- Project management experience working with DM support and cross functional team
- Vendor oversight experience - managed vendors on DM related tasks
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, For more information and to view Vertex's press releases, please visit www.vrtx.com.
- Proactive, positive approach to challenges and changes
- Critical thinking skills - can you think through a problem and offer multiple solutions - then work with a team to agree upon the correct solution for the problem.
- Execution - someone who thrives on completing tasks vs brainstorming (brainstorming is nice, but tasks need to be completed).
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information,sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vertex Pharmaceuticals - 18 months ago
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Vertex Pharmaceuticals aims to cure patients with previously incurable diseases. The biotechnology company uses an integrated,...